BOOST: Blended Onsite and Offsite Structured Exercise Training and Coaching
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorWake Forest University Health Sciences
About this trial
Heart failure with preserved ejection fraction (HFpEF) represents a major public health burden that is both growing rapidly and has few effective therapies. Supervised exercise training (SET) is one of the few effective therapies for older patients with HFpEF, but is currently constrained by cost, resource limitations, and sub-optimal short and long-term clinical response. The objective is to develop and test novel strategies to augment the therapy of exercise training to optimize response and resource utilization in older patients with HFpEF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of heart failure with signs and symptoms of heart failure and at least one of the following: Evidence of increased LV filling pressures at rest, exercise, or other provocations / Prior HF hospitalization / Elevated heart Failure with Preserved Ejection Fraction (H2FPEF) score or elevated Heart Failure Association-Pre-test, Echocardiography & natriuretic peptide, Functional testing, Final etiology (HFA-PEFF) score
Left ventricular ejection fraction ≥ 50%
New York Heart Association (NYHA) functional class II-IV
Age ≥ 55 years old
Disqualifiers
Significant change in cardiac medication or heart failure (HF) symptoms within 3 weeks prior to enrollment
Hospitalization or urgent care visit for HF within 4 weeks prior to enrollment
Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major Cardiac Vascular (CV) surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to enrolment
Uncontrolled hypertension
Trial design
Design model
Single group
Treatments tested in this trial
multi-domain behavioral, coaching, and exercise protocol
BehavioralGroup-mediated educational sessions, individual coaching contacts, group exercise sessions, and home-based self-guided exercise - Groups will engage in this iterative, trainer-guided, in-person, aerobic-based exercise and group counseling sessions approximately 2 times/week for 12 weeks.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: multi-domain behavioral, coaching, and exercise protocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame
Baseline2
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame
Week 43
Exercise self-efficacy scales Scores
Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Time frame
Week 124
Exercise Benefits/Barriers Scale Score
Evaluates how participants determine benefits of and barriers to participating in exercise.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov